MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon break occurred.An 8.0mmx80mmx135cm-hybrid sterling balloon was selected for use.However, it was noted that the balloon broke during inflation.The procedure was completed with another pre-dilation balloon.The patient left the operating room stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon break occurred.An 8.0mmx80mmx135cm-hybrid sterling balloon was selected for use.However, it was noted that the balloon broke during inflation.The procedure was completed with another pre-dilation balloon.The patient left the operating room stable.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and non-calcified ureteral pyelo-ureteral junction.During the first inflation, it was noted that the balloon ruptured when pressurized at 12 mmhg for 3 minutes.The balloon was removed without any problem using the normal method.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20944636
• Report Number: 2124215-2024-78702
• Device Sequence Number: 8323377
• Product Code: DQY
• UDI-Device Identifier: 08714729720720
• UDI-Public: 08714729720720
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0033332320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown